This is Follow-up Assessment of Resistance to ABT-333 in Hepatitis C Virus (HCV)-Infected Subjects Who Have Received ABT-333 in ABT-333 Studies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00726882
First received: July 30, 2008
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

This is a follow up study for patients that participated in a previous ABT-333 study. There is no treatment provided and only blood samples for resistance are collected.


Condition Intervention Phase
HCV Infection
Procedure: Blood sample collection only
Drug: ABT-333
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Follow-up Study to Assess the Evolution and Persistence of Resistance to ABT-333 After Discontinuation of ABT-333 Therapy in HCV Genotype-1 Infected Subjects Who Participated in Phase 1, 2, or 3 ABT-333 Clinical Studies

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Analysis of the prevalence of resistance of specific mutations over time will be summarized. [ Time Frame: Approximately 48 Weeks ] [ Designated as safety issue: Yes ]
  • Analysis of the degree of phenotypic resistance (fold change in susceptibility to ABT-333 compared to wild-type virus) will also be summarized. [ Time Frame: Approximately 48 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Summary of serious adverse events related to study procedures only. [ Time Frame: Approximately 48 weeks. ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: August 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Follow-up study that includes sample collection procedures only and no treatment.
Procedure: Blood sample collection only
Approximately monthly collection of blood samples
Drug: ABT-333
Previous treatment in prior ABT-333 studies. Follow up study that includes sample collection procedures only and no treatment.

Detailed Description:

The purpose of this study is to evaluate the development of specific viral mutations in response to treatment with ABT-333.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Main Selection Criteria: Subject received ABT-333 or matching placebo in a prior clinical study involving ABT-333.
  • A subject will not be eligible for study participation if the investigator considers the subject unsuitable for the study for any reasons inclusive of, but not limited to, failure to comply with study procedures in prior ABT-333 clinical study.

Exclusion Criteria:

There is no exclusion criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726882

Locations
United States, California
Site Reference ID/Investigator# 17665
Anaheim, California, United States, 92801
Site Reference ID/Investigator# 17367
Los Angeles, California, United States, 90036
Site Reference ID/Investigator# 17672
Los Angeles, California, United States, 90048
United States, Florida
Site Reference ID/Investigator# 10381
Orlando, Florida, United States, 32803
United States, Louisiana
Site Reference ID/Investigator# 17667
Baton Rouge, Louisiana, United States, 70808
United States, Texas
Site Reference ID/Investigator# 14461
San Antonio, Texas, United States, 78215
Puerto Rico
Site Reference ID/Investigator# 11141
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Daniel E Coihen, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00726882     History of Changes
Other Study ID Numbers: M10-459
Study First Received: July 30, 2008
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
HCV Infection

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on September 29, 2014